Newsletter - February 2015

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Cord Blood Bank Wins Record Damages From Magazine

This legal case will please every family cord blood bank that has ever been attacked in the media:
Moscow's Arbitration Court has given the largest damages award in the history of Russian media to
Human Stem Cells Institute (HSCI) for a dispute over how family cord blood banking was portrayed in a magazine.
The damages amount in rubles is equivalent to nearly USD 1 million.

The case began with an article titled "Money Made on Children's Blood" that was published in the magazine
"Russky Reportyor" (Russian Reporter) on 24 January of 2013.
The article alleged that Gemabank, the largest family cord blood bank in Russia, had disseminated false information
about the healing powers of umbilical cord blood. The article also attacked Gemabank for aggressively promoting
their services in maternity wards, a practice that is a standard marketing tactic of family cord blood banks worldwide.

At first HSCI, an open joint-stock company that owns Gemabank, simply asked Russky Reportyor to remove the article
from its website, but their request was refused.

Russky Reportyor prides itself on controversial news coverage. The magazine was launched in 2007, and since 2010
they have had the right to publish classified information taken from the WikiLeaks website.
So their refusal to remove an article about a Russian cord blood bank is not surprising.

But Russky Reporter did not bargain on the tenacity of Arthur Isaev, MD MBA, founder of HSCI.
Dr. Isaev leads a network of companies that are dedicated to researching stem cell technologies
and bringing them to market as pharmaceutical products, both in his home nation of Russia and internationally.

HSCI, working with the Polyakov Law Office, sued the magazine on 25 June 2013 for damages resulting
from their negative press coverage. HSCI claimed they had suffered both reputational and financial losses
as a result of the article, and sought damages of 75.9 million rubles (at that time worth USD 1.6 million)
from CJSC Expert Media Holding, which owns Russky Reportyor.

The ruling in this case hinged on whether the family cord blood bank had made accurate claims about the diseases treated
with cord blood and the odds of use for those diseases.
This case illustrates the importance and value of disseminating accurate public education.
Moscow's Arbitration Court issued a record ruling in favor of the plaintiff on 28 Oct. 2014.

In addition to the financial damages, the ruling also requires Expert Media Holdings to delete the original article
from the web pages of Russky Reportyor and to publish the response of HSCI.
A statement issued by HSCI read:
"We feel that the court's decision is very important not only for Gemabank and for the development of the use
of cord blood cells in medical practice, but also for journalism and business in general.
Journalists will become more aware of their responsibility, and the power and the price of their words."

To this day, Expert Media Holding has not fulfilled the requirements of the court order.

In a press release, Dr. Isaev declared:
"Despite winning in all courts during the case, we are ready to settle with Russian Reporter and the defendants
and reach an amicable agreement, even at this stage.
If this isn't possible, then we will donate all 44.4 million rubles given to us for compensation of damages and reputational harm
to charities for the treatment of children with leukemia and inherited diseases.
It is precisely for these patients and for creating treatments for similar diseases that Gemabank and the entire team
of the Human Stem Cell Institute work."

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Tracking Stem Cells After Infusion

Assaf A. Gilad, PhD, Associate Professor at Johns Hopkins University

Regenerative medicine is a new field of medicine that offers new hope for many patients.
Stem cells have the capability to induce tissue repair and ultimately reverse the progression of many diseases.
This field unveils new possibilities for the alleviation of many incurable diseases.

Treating diseases with stem cells is a powerful approach on three levels:

Stem cells have the ability to migrate into the damaged tissue, replace the non-functioning cells and take over their function.

Stem cells secrete small molecules that can prevent cell/tissue death, and help in recovery, or at least prevent deterioration of the tissue.

Stem cells can be used as a vehicle for continuous delivery of therapeutic agents locally.

However, the major challenge today with translation of stem cell therapy into the clinic is that,
after stem cells are infused, their fate is largely unknown.
Therefore, it is critical to develop new imaging technologies that can non-invasively monitor the viability and the function
of the transplanted stem cells in order to assess the success of the procedure and to ensure that the cells reach their intended destinations.

Medical imaging has revolutionized modern medicine as we know it. Essentially, no critical medical decision is taken today
without performing some sort of imaging. Magnetic Resonance Imaging (MRI) is a powerful imaging tool that can be found
in all major medical centers and is used both for diagnostics and for follow-up during and after treatment.

To address the need for visualization of transplanted cells, including but not limited to stem cells,
scientists started in the early 90's to develop new technologies.
Nanometer-sized magnetic particles (aka "nanoparticles") have been developed to track transplanted cells and have shown great success.
Those nanoparticles are usually tiny iron crystal (or crystals of other metals with magnetic properties)
wrapped with sugar-based polymers (to prevent toxicity). The nanoparticles can be inserted into stem cells in the lab.
Next the stem cells can be injected into a human body and can be imaged with MRI.

Many pre-clinical studies in animals have shown the feasibility and safety of nanoparticles.
Several clinical trials in humans were conducted around the world, showing the importance of tracking the cells in the body.
The magnetic nanoparticles are mostly beneficial for tracking the location of cells, but are limited in providing additional information,
such as whether the cells are dead or alive or actually performing the required function.
This is because dead cells still maintain the particles, and thus, are still visible with MRI.

In the past decade, we have developed a unique technology in our lab to label transplanted cells with genetically encoded "reporters".
By engineering the genome of the cells we wish to track, we can introduce molecules that can help us follow the cells
with high-resolution MRI and monitor their viability. Since these reporters are encoded into the cell's own DNA,
it ensures that the MRI signal we detect is only from live cells.
These reporters can be used to tag certain cellular proteins to monitor their function.

Recently our artificial reporter genes were proven as beneficial tools in preliminary studies in laboratory animals.
Armed with this new technology, and funding from the
Maryland Stem Cells Research Fund (MSCRF),
we aim to test the practicality of tracking stem cells in several disease models.

In summary, nanoparticles enable the non-invasive tracking of transplanted cells, and now,
the new technology of reporter genes will allow us to monitor cellular viability and function as well.
Due to the non-invasive nature of this method, and the abundance of MRI scanners in hospitals today,
we anticipate that these innovative technologies can easily be translated into the clinic.
This will enable clinicians to monitor the efficacy of regenerative medicine therapies for a large array of diseases,
and consequently improve patient safety and treatment outcome.

Assaf Gilad, Ph.D., is an Associate Professor in the Johns Hopkins Medicine Division of MR Research
within the Department of Radiology and Radiological Science.
Dr. Gilad is also an affiliate faculty member of the Johns Hopkins Institute for Cell Engineering, where he studies vascular biology.
Dr. Gilad's primary research interest is developing new biosensors and nanoparticles for use with MRI to monitor gene expression,
signal transduction gene-replacement therapy, stem-cell tracking and brain function.
He is particularly interested in using these new technologies to benefit patients with brain tumors.
Dr. Gilad earned a bachelor's degree in biology at Technion-Machon Technologi Le'' Israel before earning M.Sc. and doctoral degrees
in the same subject at Israel's Weizmann Institute of Science.

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Cord Blood as starting material for Induced Pluripotent Stem Cells

Mahendra S. Rao, MD PhD, Consultant in Regenerative Medicine

Cord blood banking, both public and private, has illustrated the power of having needed stem cells available for potential use.
It is clear that stem cells that are identical to your own are the best, followed by those from near relatives,
followed by those from donors who carry the same HLA phenotype.
By best I mean that the body does not initiate a process of rejection against them.

The reason why unrelated donors are not as good as your own cells, even when they are HLA matched, is simply because
through evolution nature has devised elaborate methods to distinguish self from non-self.
The major HLA types are only one of the methods that nature uses.
There are also minor HLA antigens, and a class of immune response termed innate immunity.
Just as nature has evolved methods to differentiate self from non-self, nature has also evolved tolerance mechanisms,
such as when a mother spends nine months pregnant with a baby that has a different HLA type.

As we humans have developed a better understanding of the immune system and rejection responses, we have been able
to develop drugs to suppress the rejection response when we perform organ transplants or stem cell transplants.
However, when drugs are used to fool the immune system into accepting a transplant, the patients must stay on the drugs
for the rest of their lives, and this leads to many long term side effects.

Recently another type of stem cell has been manufactured by scientists.
The invention of induced Pluripotent Stem Cells (iPSC) was honored by a Nobel Prize in 2012 to Dr. Shinya Yamanaka
and Dr. John Gurdon whose work Dr. Yamanaka built upon.
They showed that it was possible to take any cell from the body and, with a few gene engineering tricks, convert it into a stem cell.
The iPSC are more like embryonic stem cells from the earliest stage of fetal development than like cord blood stem cells.
The iPSC can make all the lineages of cells in a body.

Scientists do not imagine that iPSC will replace cord blood for therapeutic purposes.
Making iPSC is not as cost effective as simply banking cord blood.
Also the gene engineering involved in the manufacture of iPSC creates additional challenges
to their regulatory approval for clinical applications.

Rather scientists imagine that cord blood banks could serve as the scientific and business model for how iPSC
could be banked and distributed.
Equally important, scientists have shown that cord blood cells are a very good starting material for making iPSC.
Cord blood stem cells are immunologically pristine, are collected in the correct manner for a cell therapy starting material,
have regulatory approval for many indications, and in the public cord blood banks they are already HLA typed.

Therapy models that scientists and clinicians are proposing for iPSC-based treatments are summarized in the figure below.
In the middle column named One to Many, one batch of iPSC can be made, cryopreserved, and used to treat hundreds of thousands of people.
While patients would have to take immune suppression to prevent rejection, the cost of making the cells and distributing them would be
cheap when done on a mass scale. Scientists also hope that we may discover additional less costly methods to suppress the immune system.

Other scientists have suggested that in parallel we could develop a Many to Many treatment model
by making a few lines of super-donor iPS which can be used to treat multiple individuals
because they have ancestral HLA types that do not trigger strong rejection reactions.
This is analogous to banking a blood transfusion from a donor who has blood type O-negative,
which can be tolerated by patients of all blood types.
Scientists estimate that as few as 200 super-donor iPSC lines may be sufficient to treat most individuals.

The third One to One strategy is akin to how family cord blood banks operate already.
Collect some of your own stem cells and bank them, plus make iPSC from them for companion storage.
These personalized iPSC would be the best match for yourself and could be used as a self-renewable source
of multiple cell types that you may need at different times in your life.

The ability of cord blood banks to participate in this exciting new field has important implications for people choosing to store cord blood.
The amount of cord blood collected at birth is no longer a limitation. If a small portion of the cord blood was used to make iPSC,
while the bulk was banked as usual, then the additional cells generated on the iPSC pathway could provide for multiple
additional therapies from the original cord blood donor.
Moreover, should they choose, a donor could provide iPSC cells to others without depleting the cells they needed for themselves.

The combination of cord blood plus iPSC banking is a win-win for all based on the larger dividing capacity of the iPSC cell.
Cord blood banks could and should develop a strategy to provide this exciting option to their clients.
Parents should ask family cord blood banks, what is their ability to make and store iPSC from cord blood?

Mahendra S. Rao received his MD (MBBS) from Bombay University in India, and
his PhD in Developmental Neurobiology from the California Institute of Technology.
Dr. Rao is internationally known for his research involving human embryonic stem cells (hESCs) and other somatic stem cells.
He has worked in the stem cell field for more than twenty years,
with stints in academia, government and regulatory affairs, and industry.
Dr. Rao has published more than 300 papers on stem cell research and is the co-founder of the
neural stem cell company Q Therapeutics based in Utah and more recently NxCell based in California.
Dr. Rao has served on the boards of several stem cell and regenerative medicine companies and has served on numerous
scientific advisory boards for pharma companies, journal editorial boards, oversight committees, and national governments.
Dr. Rao has served as the Chair of the FDA's CBER advisory committee (CTGTAC)
and most recently served as the CIRM and ISSCR liaison to the ISCT.
Dr. Rao was the founding Director of the NIH Center of Regenerative Medicine
and also the Chief of the Laboratory of Stem cell Biology at the NIH.
Dr. Rao is currently a consultant on regenerative medicine for the New York Stem Cell Foundation.
Dr. Rao was recently named one of the top ten influential people in the stem cell field and was
honored by the Federation of Biologists (FABA) India for his achievements in the stem cell field and
awarded the NBRI medal (India) for his contributions to neuroscience research.
Just this month, Dr. Rao was appointed to the
Scientific and Medical Advisory Board
of Cord Blood Registry.

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